Imaging systems and methods

ABSTRACT

Methods and systems for x-ray and fluoroscopic image capture and, in particular, to a versatile, multimode imaging system incorporating a hand-held x-ray emitter operative to capture digital or thermal images of a target; a stage operative to capture static x-ray and dynamic fluoroscopic images of the target; a system for the tracking and positioning of the x-ray emission; a device to automatically limit the field of the x-ray emission; and methods of use. Automatic systems to determine the correct technique factors for fluoroscopic and radiographic capture, ex-ante.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/163,878 filed Feb. 1, 2021, which is a continuation of PCTApplication No. PCT/US2019/044727 filed Aug. 1, 2019, which claimspriority to U.S. Provisional Applications 62/712,981 filed Aug. 1, 2018and 62/817,561 filed Mar. 13, 2019, the entireties of all applicationsare incorporated by reference herein.

FIELD OF THE INVENTION

This invention relates generally to improved methods and systems forx-ray and fluoroscopic image capture and, in particular, to a versatile,multimode imaging system incorporating a hand-held x-ray emitteroperative to capture digital or thermal images of a target; a stageoperative to capture static x-ray and dynamic fluoroscopic images of thetarget; a system for the tracking and positioning of the x-ray emission;a device to automatically limit the field of the x-ray emission; andmethods of use. The invention also includes an automatic system todetermine the correct technique factors for fluoroscopic andradiographic capture, ex-ante. By utilizing a sensor driven, iterative,networked and continually improving computational approach, a faster andmore accurate image can be captured without operator input whilesimultaneously reducing dose to the patient, operator and staff.

BACKGROUND OF THE INVENTION

Current fluoroscopic machines for orthopedic surgery tether a radiationsource to an image intensifier by way of a large, fixed ‘c-arm.’Manipulation of these larger, less portable machines is difficult andtime consuming. It is frequently necessary to reposition the subject tofit the attainable field of view, which can be problematic duringsensitive stages of a procedure. Thus, while c-arms are ergonomicallysuitable for surgical treatment of the spine and larger joints, existingunits are heavy and cumbersome with respect to hand/wrist/arm andfoot/ankle/leg extremity surgery, where relevant anatomy is smaller andmore moveable by the surgeon. Existing fluoroscopic machines are alsoexpensive and emit large doses of radiation. In many cases, these largerradiation doses are not required for more delicate procedures, onextremities, for example, unnecessarily exposing the patient and surgeonto these higher doses.

In today's surgical environment, digital pictures and video are oftenneeded to document relevant surgical anatomy or pathology. Thermalimaging can also be a useful tool, particularly for the extremitysurgeon. Thermal imaging may be used to help determine if blood supplyto an extremity or digit is threatened, and if a revascularizationprocedure is required. The addition of thermal imaging provides a quickand simple tool to guide intra-operative decisions. However, becauseexisting fluoroscopic machines only capture x-ray images, the need toswitch between digital and/or thermal image capture devices may create adelay in the completion of the surgery. Further, in a number ofsituations, the digital or thermal camera is not a sterile device,forcing the surgeon to either violate the surgical field, take a pictureand then scrub back in, or have an assistant take the picture, which cancreate confusion about image correlation.

Historically, x-ray images have been captured using an image intensifierdevice. Due to their design and construction the active area of thesedevices is traditionally circular. Because of the manufacturing process,the active area of modern x-ray detectors utilizing digital componentsare typically rectangular in nature.

In order to provide a safe operating environment for the user andsubject, it is necessary to ensure that the x-ray emission onlyilluminates the active area of the x-ray detector. To achieve thissafety condition, a device is placed directly in the path of the x-raybeam that restricts the size and shape of the beam. This device iscalled a collimator.

In most fixed position x-ray systems, where the orientation and distancebetween the x-ray source and x-ray detector is fixed, there is a staticcollimator that is typically sized and positioned during a calibrationprocess. This calibration process happens infrequently, typically onceper year.

In most dynamic position x-ray systems, where the orientation of thex-ray source is fixed, but the distance between the x-ray detector andx-ray source is variable, there will be a collimator that can adjust thesize of its aperture as the distance between the detector and sourcechanges.

Novel freely positioned x-ray systems use an array of sensors to allowan operator to place the source and detector in any orientation. From acollimation standpoint, this creates a new set of challenges that arenot addressed by traditional collimator designs.

In order to illuminate the full rectangular field of view of the x-raydetector while allowing the operator to orient the source in anyposition, it is necessary to utilize a dynamic, rolling collimator.Utilizing a sensor array, the device can adjust the square projectiononto the detector regardless of alignment position by adjusting the sizeand angular offset of the collimator within the source.

There is an outstanding need, therefore, for a small, lightweight systemand method that allows the surgeon to capture x-rays withoutrepositioning equipment.

There is also a need for improving the quality of an x-ray orfluoroscopic capture where the quality is related to a number ofphysical attributes of the subject. These elements dictate a set oftechnique factors (eg: power, current, time) that control the emissioncharacteristics of the radiation source. It is the responsibility of thedevice operator to set these factors in such a combination that theinterpreter can see the necessary visual elements without exposing thesubject to excess radiation.

Setting these technique factors can be complex. In order to relieve theoperator of the burden of setting these techniques manually, existingfluoroscopic devices have implemented an automatic process. The typicalapproach uses a software or a hardware dose detector on the plate thatgradually fills as radiation is added to the exposure. This approach hasa number of problems.

The major issue with the existing approach is movement. Because theradiation is exposing the subject for an extended time period, anymovement whatsoever, either in the subject, the operator, the machine,vascularity inside the subject, etc., will create motion artifacts thatseverely degrade the image.

Also, in traditional systems, penetration requirements are not knownbefore the exposure; therefore, as the source emits radiation at a givenpower level (kV), frequently there is not be enough penetration torender an image. This failure to render an image exposes the patient,operator and staff to excess radiation without any clinical purpose.

There remains a need for applying the capabilities of the new generationof systems having complex sensor arrays, capable of directly measuring anumber of the physical elements required for exposure calculation andusing these improved systems to apply learning algorithms that assistthe medical practitioners in obtaining an optimal radiological image.

By utilizing sensors across the full spectrum of the improved systemsand subjects, as well as robust machine learning techniques, it ispossible to compute the necessary techniques before the patient isexposed to radiographic energy, which can eliminate motion artifacts andcreate an outstanding capture of the radiological image, all whilereducing an exposure dose.

SUMMARY OF THE INVENTION

The invention relates to an improved versatile, multimode radiographicsystems and methods, allowing the surgeon to operate on a patientwithout interference, and capture static and dynamic x-rays and otherstill and video imagery without repositioning equipment, the subject orthe surgeon.

Both x-ray emitters and detectors are described. One variation of anovel emitter allows for portable control of the emitter. Such anemitter can be lightweight and extremely maneuverable. Variationsinclude that the portable emitter that is a handheld unit.Alternatively, the portable emitter can be affixed to a mountingstructure that is either automated/controllable or simply bears theweight of the emitter to prevent the user from constantly holding theemitter. In additional variations, the emitter can be designed so thatit is releasably coupleable with a mounting structure, which allowsimproved portability when needed and coupling to a mounting structurewhen desired. The emitter may include both an x-ray emitter along withat least one additional imaging modality such as a digital camera forproducing a visual image, a thermal image, and an infrared image of apatient for the purposes of aiding diagnostic, surgical, andnon-surgical interventions. Clearly, the systems and methods describedherein can be used for non-medical applications where non-invasiveimaging is desirable.

Ergonomic controls make acquisition of images easier and faster and abuilt-in display facilitates easy-to-use control functions. The devicesenses its distance from the subject and will block the activation anddischarge of radiation if the x-ray tube is not at a safe distance;i.e., too close to the patient. The minimum distance can be defined insoftware and is adjustable based on intended use and other factors. Thesystem automatically and intelligently manages its power state throughthe implementation and use of an inertial measurement unit (IMU) andvarious timing components.

The x-ray emitter may be used with any available x-ray detector. Oneoption is to mount the emitter in a fixture including a properly aligneddetector plate, much like a traditional c-arm, though much smaller andmore capable. An alternate variation is described herein and includesuse of an emitter with a distinct x-ray capture stage, disclosed indetail, which automatically pivots, orients and aligns itself with theemitter to maximize exposure, quality and safety.

The inventive x-ray stage comprises a statically fixed platform,positioned during the outset of surgery, with an open cavity containingan x-ray sensor, an x-ray sensor positioning system, an emitter trackingsystem, a shielding system and a control unit. Optionally, the systemcan utilize an external display monitor or any other method forreviewing the captured image.

A variation of the improved systems described can include a non-invasiveimaging system for examining an object for medical and non-medicalinspections. Such a non-invasive imaging system can include an emittingapparatus configured to emit energy; an imaging sensor configured togenerate an imaging signal upon the receipt of the energy when theemitting apparatus and imaging sensor are in an operationally alignedposition; a platform having an external surface for positioning of theobject and comprising at least one positioning mechanism locatedadjacent to the external surface; at least one positioning mechanismcoupled to the imaging sensor allowing for movement of the imagingsensor adjacent to the external surface; at least one position trackingelement affixed relative to the platform; where the emitting apparatusis moveable relative to the external surface of the platform; and acontrol system configured to determine a first coordinate measurementbetween the at least one position tracking element and the imagingsensor, the control system configured to determine a second coordinatemeasurement between the emitting apparatus and the at least one positiontracking element, where the control system uses the first coordinatemeasurement and the second coordinate measurement to control actuationof the positioning mechanism moving the imaging sensor into the alignedposition during or after movement of the emitting apparatus.

A variation of the improvements described herein also includes animproved method for non-invasively imaging an object. For example, sucha method can include moving an emitting apparatus to a location relativeto the object; determining a position of the emitting apparatus relativeto at least one position tracking element; relaying the position of theemitting apparatus to a motor system that adjusts an imaging sensor intoan operative alignment with the emitting apparatus; emitting energy fromthe emitting apparatus when the imaging sensor is in operative alignmentwith the emitting apparatus; and transmitting an image signal from theimaging sensor to a display.

Another variation of the method can include non-invasively imaging anobject, by moving an emitting apparatus to a location relative to theobject; emitting energy from the emitting apparatus to the object suchthat the energy is received by an imaging sensor configured to generatean image data; determining a position and orientation of the emittingapparatus relative to at least one position tracking element located ina fixed position relative to the image sensor; adjusting an image databased using the position and orientation of the emitting apparatus; andtransmitting the image data to a display.

Variations of the system can include platforms that have a planarsurface allowing for positioning of the object. Alternatively, aplatform can include a support frame that allows securing of the objectover a free-space such that the portion of the object located in thefree-space can be viewed or inspected either entirely or substantiallyaround the perimeter of the object.

In the systems, devices and methods described herein, which position theemitter and sensor in alignment or operative alignment, the degree ofalignment can include any industry specifications that dictatealignment. For example, for medical applications, alignment of thesystems and methods described herein can include a degree of alignmentrequired to comply with the U.S. Code of Federal Regulations applying tothe FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES(e.g., 21 C.F.R. part 1020 incorporated by reference herein.) E.g.,under 21 C.F.R. Neither a length nor a width of the x-ray field in theplane of the image receptor (sensor) shall exceed that of the visiblearea of the image receptor (sensor) by more than 3 percent of thesource-to-image receptor distance (SID) and the sum of the excess lengthand the excess width shall be no greater than 4 percent of the SID andAny error in alignment shall be determined along the length and widthdimensions of the x-ray field which pass through the center of thevisible area of the image receptor. In other applications, or alternatejurisdictions, the alignment discussed herein can vary to meet therespective requirements. Alternatively, variations of the systems,devices, and methods can include such metrics as obtaining a nearorthogonal positioning between an emitter and receptor.

As with alignment, a minimum or maximum distance between an emitter andreceptor can be established by industry standards. In one example, usingthe above FDA regulations, a maximum source-image receptor distance ofless than 45 cm and means shall be provided to limit the source-skindistance to not less than 19 cm.

In use, the stage precisely tracks the position and angle of the x-rayemission, positioning and tilting the embedded sensor exactly to capturea precise, high quality x-ray image. The stage uses less power, correctsfor any skew or perspective in the emission, allows the subject toremain in place, and allows the surgeon's workflow to continueuninterrupted.

In a “clinical” embodiment, an x-ray capture stage is staticallypositioned, with the emitter using the positioning to ensure theemission is only fired when the emission can be positively captured bythe active area of the capture stage. Firing is also immediatelyterminated if acquisition of this positive capture is lost.

Another variation of an improved system for radiological imaging of anobject includes an emitting apparatus configured to emit energy under aplurality of output parameters upon initiation of the emittingapparatus; an imaging sensor configured to generate a radiologicalimaging signal upon the exposure of energy to the imaging sensor;

-   -   a position tracking system comprising a plurality of sensors        coupled to the emitting apparatus or the imaging sensor, the        position tracking system configured to track an orientation        between the emitting apparatus and the imaging sensor;    -   a camera configured to capture an image of the object; and a        controller configured to:        -   determine at least one sensor parameter of the position            tracking system when tracking the orientation of the            emitting apparatus relative to the imaging sensor and            confirm that the at least one sensor parameter of the            emitting apparatus relative to the imaging sensor satisfies            at least one or more operational safety parameters;        -   analyze the image of the object to assign a classification            to the object using a computer vision classifier database            comprising previously obtained images;        -   estimate at least one inferred operational parameter using            the at least one sensor parameter, the classification of the            object, and an estimator database of previously obtained            data including sensor parameters;        -   set at least one of the output parameters of the plurality            of output parameters to the at least one inferred            operational parameter and initiate emission of energy from            the emitting apparatus;        -   process a radiological image using the radiological imaging            signal produced by imaging sensor from the exposure of            energy; and        -   transmit the radiological image to a display.

The controller can be further configured to record at least one userinteraction with the system to adjust the radiological image.

In one variation the at least one user interaction comprises anadjustment to the radiological image selected from the group consistingof brightness, sharpness, contract, position, zoom, rotation, and acombination thereof. The user interaction with the system can comprisemanipulation of the radiological image.

Variations of the system include a controller that is configured torecord a time duration of the user interaction with the system to adjustthe radiological image.

The one or more operational safety parameters can include a parameterselected from the group consisting of source-to-object distance,source-to-detector distance, angle of incidence, alignment of source tosensor, and temperature of the emitting apparatus.

The controller can be further configured to estimate at least oneinferred operational parameter using the at least one or moreoperational safety parameters.

In another variation, the controller further determines alignmentbetween the imaging apparatus and the image sensor using the positiontracking system.

Variations of the system can be used where the object comprises a bodypart of a patient and wherein the controller is further configured todetermine the at least one inferred operational parameter additionallyusing a CPT code.

In another variation of the system, the controller is further configuredto determine the at least one inferred operational parameteradditionally using a biometric data.

The systems described herein can further include one or more datastorage units. Such data storage units can include a database ofreference images, and wherein the controller is configured to analyzethe image of the object using the database of reference images. In anadditional variation, the data storage unit comprises at least onestatistical model associating radiological parameters with a pluralityof historical sensor data and a plurality historical classificationdata, and wherein the controller is configured to determine the at leastone inferred operational parameter additionally using the statisticalmodel.

The present disclosure also includes methods for radiological imaging ofan object, where such a method includes providing a radiological imagingsystem comprising an emitting apparatus, an imaging sensor, a positiontracking system comprising at least one sensor, and a camera, wherein:the emitting apparatus is configured to emit energy under a plurality ofoutput parameters upon initiation of the emitting apparatus;

-   -   the imaging sensor is configured to generate a radiological        imaging signal upon the exposure of energy to the imaging        sensor;    -   the position tracking system and at least one sensor is        configured to track an orientation between the emitting        apparatus and the imaging sensor; and    -   the camera configured to capture an image of the object;

-   determining at least one sensor parameter when tracking the    orientation of the emitting apparatus relative to the imaging    sensor;

-   confirming that the at least one sensor parameter satisfies at least    one or more operational safety parameters;

-   assigning a classification to the object by analyzing the image of    the object using a computer vision classifier database comprising    previously obtained images;

-   estimating at least one inferred operational parameter using the at    least one sensor parameter, the classification of the object, and an    estimator database of previously obtained data including sensor    parameters;

-   setting at least one of the output parameters of the plurality of    output parameters to the at least one inferred operational    parameter;

-   initiating emission of energy from the emitting apparatus;

-   processing a radiological image using the radiological imaging    signal produced by imaging sensor from the exposure of energy; and

-   transmitting the radiological image to a display.

In another variation a method under the present disclosure includesmethods for determination of an automatic exposure setting for any of aplurality of radiological imaging systems, where each radiologicalimaging system includes a camera, an emitting apparatus, an imagingsensor, one or more sensors, and a controller that is configured to usethe one or more sensors to track an orientation between the emittingapparatus and the imaging sensor, the method comprises:

-   -   compiling a global metric database including data selected from        the group consisting of sensor data, interaction data, surgical        data, and a combination thereof, where data is collected over        time from any of the plurality of radiological imaging systems,        the sensor data comprising direct measurements from the one or        more sensors, the interaction data comprises interactions of an        operator interacting with any of the plurality of radiological        imaging system to adjust a radiological image, and the surgical        data comprises surgical detail of any patient examined by any of        the plurality of radiological imaging systems;    -   compiling a capture storage database comprising a raw capture        data from any of the plurality of radiological imaging systems;    -   analyzing a statistical relationship between the sensor data,        the interaction data, the surgical data from the global metric        data and a previous estimator data, where the previous estimator        data comprises a previously captured sensor data, a previously        captured interaction data, and a previous captured surgical        data, where analyzing the statistical relationship produces a        revised estimator data;    -   analyzing the raw capture data, surgical data and a current        computer vision classifier data to produce a revised computer        vision classifier data;    -   transmitting the revised estimator data and the revised computer        vision classifier data to an active radiological imaging system,        such that the active radiological imaging system is enabled to:    -   i) analyze an image of an examined patient taken from a camera        of the active radiological imaging system using the revised        computer vision classifier data to assign a classification to        the image; and    -   ii) estimate at least one inferred operational parameter for the        active radiological imaging system using sensor data, the        classification and the revised estimator data.

In one variation of the method, compiling the capture storage databasefurther includes information on a specific radiological imaging systemthat generates the raw capture data.

In another variation of the method, the interaction data includes anadjustment to the radiological image selected from the group consistingof brightness, sharpness, contract, position, zoom, rotation, and acombination thereof. The interaction data can include a time duration ofa user interaction with any of the plurality of radiological imagingsystems to adjust the radiological image. The surgical data can compriseone or more CPT codes.

In another variation of the method, transmitting the revised estimatordata and the revised computer vision classifier data to the activeradiological imaging system comprises storing the revised estimator dataand the revised computer vision classifier data on a storage device incommunication with the active radiological imaging system.

This application is related to U.S. application Ser. No. 15/716,099filed Sep. 26, 2017, which claims benefit to Ser. No. 15/706,018 filedSep. 15, 2017 which claims priority to U.S. Provisional PatentApplication Ser. No. 62/394,909, filed Sep. 15, 2016; U.S. ProvisionalPatent Application Ser. No. 62/394,956, filed Sep. 15, 2016; U.S.Provisional Patent Application Ser. No. 62/471,191, filed Mar. 14, 2017;and U.S. Provisional Patent Application Ser. No. 62/504,876, filed May11, 2017; and wherein the entire content of each Application isincorporated herein by reference. This application also incorporates PCTapplication PCT/US2017/051774 filed Sep. 15, 2017 by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A depicts an example of an operating room layout for use of thex-ray imaging system in a standard surgery of an extremity case.

FIGS. 1B and 1C depict an alternate example of an operating room layoutfor use of the imaging system with a specialized operating table thatimproves access to an area of a patient.

FIG. 2 is a simplified, schematic representation of an x-ray emitteraccording to the invention.

FIG. 3 illustrates one embodiment of a control panel for use with anemitter.

FIG. 4 shows a safety lockout procedure for an x-ray emitter.

FIG. 5 depicts a representative sequence for emitter power management.

FIG. 6 illustrates a process by which a device captures concurrentimages at the request of a user.

FIG. 7 is a drawing that illustrates the overall components of apreferred embodiment of a capture stage.

FIG. 8A is an oblique view of a sensor positioning system.

FIG. 8B illustrates infrared (IR) positioning tiles.

FIG. 9 is diagram that shows x, y movement of a sensor tray viewed fromabove.

FIG. 10A is an oblique diagram showing a band-operated image capturestage.

FIG. 10B is a schematic diagram of a band-operated stage with anidentification of important components.

FIG. 11A is a side view showing a sensor tilt operation.

FIG. 11B is a side view showing a sensor panning operation.

FIG. 12A illustrates an arrangement whereby emitter need not be providedon an image stage platform.

FIG. 12B illustrates additional arrangements of the imaging system wherea sensor can be configured to capture lateral views by moving above aplane of the table.

FIG. 13 is a view of an infrared emission device emitting infrared from5 points allowing for relative position calculation in 3-dimensionalspace.

FIG. 14 illustrates a safety lockout of the capture stage based upon thedisposition of the emitter.

FIG. 15 illustrates the capture of a fluoroscopic image.

FIG. 16 is a view showing the x-ray emission device with an aperturecreating the widest cone.

FIG. 17 a view showing the x-ray emission device with an aperturecreating a narrow cone.

FIG. 18 shows a control unit operative to adjust the aperture and cone.

FIG. 19 is a labeled view illustrating relative distances.

FIG. 20 illustrates a situation where an emitting apparatus casts anenergy profile that exceeds a profile of an imaging sensor.

FIG. 21A represents a situation in which an emission profile extendsbeyond a sensor such that the emitter is not in operative alignment withthe sensor.

FIG. 21B represents a situation in which an emission profile is scaledto remain within a perimeter of an imaging sensor and is in operativealignment with the sensor.

FIGS. 22A and 22B illustrates an example of the effect of an adjustablecollimator to produce an adjusted emission profile that is scaled and/orrotated to remain within the perimeter of an imaging sensor.

FIG. 23 shows a variation of an adjustable collimator that can be usedin or with an emitting apparatus.

FIG. 24A shows an exploded view of an example of an adjustablecollimator.

FIG. 24B illustrates a front view of some of the components of theadjustable collimator of FIG. 24A

FIG. 24C illustrates a rear view of some of the components of theadjustable collimator of FIG. 24A.

FIGS. 25A and 25B illustrate an example of an emitter having anadjustable collimator.

FIGS. 26A to 26J illustrates an example of a validation method for thecollimator discussed herein.

FIG. 27 illustrates an example of a traditional automatic exposureprocess.

FIG. 28A illustrates an improved system that relies upon one or moredatabases to provide machine learning for determination of exposuresettings for a radiological image.

FIG. 28B illustrates a process of improving the automatic exposureprocess and databases using feedback from the systems described herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1A depicts an example of operating room layout for use of animaging system in a standard surgery of an extremity case. In thisexample, the surgeon 102 is operating on the patient's left hand. Thepatient 104 is lying in the supine position with the left upperextremity prepped and draped on a hand table 105 in the abductedposition. The surgeon sits adjacent to the patient's side while asurgical assistant 106 sits across the hand table adjacent to thepatient's head. Surgical instruments and equipment are laid out on theback table 108 immediately behind the surgical assistant.

In one variation, the imaging system uses x-ray imaging. As such, asterilized x-ray emitter 110 according to the invention is placed on thesurgical hand table 105 for use. A monitor 112 is positioned on a standimmediately adjacent to the hand table whereby x-ray, fluoroscopic,thermal and digital images can be wirelessly transferred from the x-rayimaging system to the screen for surgeon view. The emitter 110 allowsthe surgeon to hold it with one hand while operating another instrumentsuch as a drill in the other hand. A detector stage according to theinvention may be placed on or in the table 105 to gather radiographicimagery for storage and/or viewing on an external monitor such as device112. As discussed herein, the emitter can be handheld or can be affixedto a mounting structure that is either automated/controllable or simplybears the weight of the emitter to prevent the user from constantlyholding the emitter.

FIG. 1B illustrates an additional variation of a system including asensor 706 and an emitter 710 for use with a specialized operating table300. As shown, the operating table 300 includes structures 302 thatstabilize the patient while allowing increased access around thepatient's organs since a portion of the organ is suspended in freespace. In this variation, a shell 707 containing the sensor 706 (asdiscussed below) is coupled to a first boom or arm 716. The arm/boom 716allows for movement of the sensor 706. In an alternate variation, theboom 716 can be automated such that the sensor 706 is coupled directlyto a controllable boom 716. Likewise, the emitter 710 is coupled to asecond arm or boom 714 that can be affixed to a wall, ceiling orportable frame structure. FIG. 1C illustrate positioning of the sensor706 and boom 716 adjacent to a body part of the patient 104 such thatthe emitter 710 can be positioned as desired by the operator or medicalpractitioner. In variations of the system, the boom or arm can alsohouse components of the device, such as a heat sink, power supply, etc.allowing for a more compact and easy to maneuver emitter. In addition,either boom can be designed with features to aid the physician inperforming the procedure. For example, the boom can incorporate alocking system so that the physician can position either the sensor 706and/or emitter 710 and then lock the associated boom into position.Additionally, or in combination, booms can incorporate memorypositioning such that the boom can automatically retract away from thesurgical space to a pre-determined location such that it automaticallymoves out of the way of the physician when performing a procedure. Inaddition, memory locations can include the “last location” of theemitter or sensor, such that the system can automatically reposition thecomponents in their last position prior to being moved away from thesurgical space.

FIG. 2 is a simplified, schematic representation of an x-ray emitteraccording to the invention. The general configuration of the device isto be hand held, lightweight and extremely portable. The devicepreferably has a rounded, contoured handle to ergonomically fit thesurgeon's hand and better direct fluoroscopy, digital and thermalimagery to the extremity and surgical field. Note that the drawing ofFIG. 2 is not intended to depict any particular ornamental appearance.

The back of the emitter 110 has a control panel whereby at least threedifferent modes of operation can be activated: fluoroscopic mode,digital picture mode, or infrared thermal imaging mode. Once activated,each mode is controlled in the front of the device by a trigger 202.Pressing the trigger once activates the device to take a single image(i.e., single x-ray or digital picture). Different modes of operationmay be activated in different. As one example, holding the trigger 12down may activate live fluoroscopy, digital video, or infrared thermalimaging. FIG. 2 also illustrates the emitter 110 as being coupled to apower supply 221. The power supply can be a battery 221 located remotefrom or within the emitter 110. Alternatively, or in combination, thepower supply 221 can be coupled via wiring between the emitter 110 andpower supply 221. In an additional variation, the battery 221 can bepositioned within the emitter 110 and used in addition to a remote powersupply 221 such that the emitter 110 can be disconnected from theexternal power supply temporarily with the internal battery 221 beingused to provide power.

FIG. 3 illustrates one embodiment of the control panel for use with theemitter. The control panel is located on the rear of the emission handleand controls the various inputs and outputs of the system. The controlpanel is easily accessible for the user and is ergonomically designed toease the manipulation of the emitter. The control panel comprises alarge, clear screen 204 (i.e., LCD or OLED), a control button 302located on the left of the unit, a control button 304 located on theright of the unit, and a center, clickable toggle button 206 located inthe center.

Display screen 204 displays images and a digital control panel tocontrol fluoroscopic, digital camera and infrared settings. The controlpanel may include a touch screen. Toggle button 206 controls power inputin fluoroscopic and infrared modes, and digital zoom in the picturemode. The preferred emitter configuration houses a dynamic x-raycollimating cone 210, digital camera lens 212, infrared camera 214 anddistance sensor 216. The digital and infrared cameras preferable usecharge-coupled device (CCD) technology. The distance sensor may beinfrared, acoustic or other operative technology known to those of skillin the art of proximity and distance measurement. The sensor 216continuously senses its distance from the patient and will block theactivation and discharge of radiation if the x-ray tube is too close,for example, if less than 19 centimeters directly from patient. Inaddition, the system can include any number of auditory, visual, ortactile indicators to allow a physician or user of the system todetermine that the sensor is within an acceptable distance or ready tofire. In additional variations, the auditory, visual, and/or tactileindicators are positioned such that the operative state of the system isidentifiable without the need for the user to remove his/her focus fromthe object being examined. In one example, a visible indicator (e.g.,one or more LEDs) is positioned on the emitter, which provides clearlydistinguishable feedback regarding the distance, alignment, or any otheroperational conditions of the system.

The handle 200 tapers to the bottom of the device, which may househigh-voltage power supply 218, external charging port 220 and batterydocking station 222. Upon activation of the trigger 202 in x-ray orfluoroscopic modes, high voltage from power supply 218 is fed to x-raygeneration unit 230 via the high voltage connector assembly 228. Powerproduced by power supply 218 is converted to a suitable input voltagethat can be used by the x-ray generation unit 230. This power rangesfrom 1 kV to 120 kV, but typically ranges between 30 kV to 90 kV inconjunction with clinical application.

The x-ray generation unit 230 is based upon existing high-voltageemitters, though custom designed for small size required of the instantapplication. A suitable thickness of electrical insulating materialsurrounds the high voltage power supply 218, connector assembly 228 andthe x-ray generation unit 230 to prevent radiation loss and preservegood beam quality. All three components 218, 228, 230 are placedimmediately adjacent to each other to minimize high voltage leakage andpossible interference with low voltage components in the system. In analternative embodiment, components 218, 228, 230 may be disposed in anexternal control unit (not shown).

A suitable layered combination of silicone rubber and epoxy encapsulatesthe x-ray generation unit 230 (except where x-rays are emitted intocollimator) in order to shield radiation losses and dissipate hightemperatures generated by x-ray tube operation. Radiation is produced bythe x-ray tube and transmitted via the collimating cone 210 at the headof the device. Fluoroscopic settings including peak kilovoltage (kV),amperage (mA), and digital brightness, which are controlled by thedigital control panel on the back of the neck.

The digital camera lens 212 and infrared thermal camera 214 areimmediately adjacent to the collimating cone 210, and these componentsare also shielded by insulation. The digital camera 214 is controlled bythe placing the device in digital mode using the control panel. Picturesare generated via the trigger 202 located on the device handle.

Similarly, the infrared thermal camera 214 is controlled by the placingthe device in infrared mode using the control panel. Live, infraredthermal imaging is generated by holding the trigger down. Digitalx-rays, traditional digital visible and thermal images may betransferred and displayed on the external screen 112 shown in FIG. 1.Depending upon the level of cooperation between the emitter and thedetector described herein below, x-ray images may be transferreddirectly to the external monitor for viewing. A memory 233 may be usedto store any type of gathered image, and such images may be encryptedupon capture in accordance with co-pending U.S. patent application Ser.No. 15/466,216, the entire content of which is incorporated herein byreference. An audio pickup 235 may be provided for procedurememorialization or other purposes, and the recordings may also be storedin memory 233, optionally in encrypted form as well.

The device is powered by an external, plugin power supply with externalcharging port 220. The digital display, control interfaces, and triggerare controlled via the control system microprocessor electronic controlunit 232 powered by a low voltage power amplifier system 234. The lowvoltage amplifying system 234 and the microprocessor control system 232are also conveniently located away from the high voltage power supply tofurther minimize interference.

The following Table lists the various control modes associated with theemitter using the buttons and toggle switch on the control panel of FIG.3:

Mode Control X-Ray Digital Thermal Center (206) Switch to Digital Switchto Switch to Thermal X-Ray Left Button (302) Increate Output ToggleMacro Decrease Power Exposure Right Button (304) Decrease Output Zoom InIncrease Power Exposure

For a variety of reasons, both practical and certification, it isimportant to maintain a minimum distance between the subject and thex-ray generator. This distance can change depending on a number offactors and can be configured in the emitter's software. FIG. 4 shows aprocess by which the device manages a safety lockout procedure of thex-ray emitter. The process to determine the safety lockout is asfollows:

402. The user initiates the x-ray emission process by depressing thetrigger while in x-ray mode. This could be for either a fluoroscopic orstill x-ray image.

404. A distance setting is retrieved from the emitter's distance settingdatabase.

405. The distance measurement unit is activated and captures thedistance between the end of the emitter and the subject directly infront of the emitter.

406. The distance setting and distance measurements are relayed to theemitter's ECU Computation unit.

408. At 408, the ECU Computation unit uses the distance measurement,distance setting and an internal generator offset to determine if theemitter should fire.

410. The fire/warn decision at 410 is determined by the ECU and relayedto the hardware units.

412. At 412, if the ECU determines that the subject is too close to theemitter, the unit will activate a warning procedure, displaying amessage on the LCD panel and activating any lockout warning lights.

414. If at 414 the ECU determines that the subject is at a safedistance, the emitter will begin the x-ray generation and emissionprocess, signaling all internal and external components.

Due to the fact that the device can move freely in 3-dimensional space,the projected cone from the x-ray emitter varies in size based on thedistance to the target. As such, the invention allows managed controlover the cone size based on the distance of the x-ray emission devicefrom a sensor positioned on the stage.

FIG. 16 illustrates a simplified rendition of an applicable x-raysource, which includes an anode 1602 and cathode 1604. The anodetypically includes a tungsten or molybdenum target 1606. High voltageacross the anode and cathode causes x rays to be produced at the target,which forms a cone 1608 that exits through an aperture 1610 in casing1612.

One aspect of the invention includes a telescoping chamber positioned inthe direction of the aperture and sensor. The distance from the x-raysource to the output aperture can be increased or decreased by rotatingthe exterior chamber along a threaded interior mount. Moving theaperture closer to the source creates a wider angle, while moving itfarther from the source reduces the angle, as shown in FIG. 17.

Making reference to FIG. 18, a control unit 1802 in the hand-heldemitter controls the telescoping aperture. Based upon the process below,the control unit 1802 rotates a threaded shaft 1804, whereupon thethreads engages with grooves 1806 in telescoping chamber 1614, causingaperture 1610 to toward and away from the x-ray source.

Referring to FIG. 19, the control methodology is as follows. First, thedistance between the device's x-ray origin and the x-ray sensor iscalculated. If the distance is outside an acceptable range of x-rayemission then no x-rays will be emitted. However, if the distancebetween the x-ray origin and the sensor (d_(s)) are within theacceptable range, the aperture will be automatically moved into place.The distance between the x-ray origin and the aperture (d_(a)) is thencalculated and the control unit rotates the aperture chamber to thecorrect distance.

If R_(s) represents the radius of the x-ray emission as it contacts thesensor, then the angle between the normalized vector of the sensor plateand the dispersion cone can be represented as θ=tan⁻¹(R_(s)/d_(s)). Thedistance that the aperture will need to be located from the emissionorigin to emit the correct dispersion of x-rays can calculated asd_(a)=R_(a)/tan(θ) where R_(a) represents the radius of the aperture.The control unit then allows the x-ray emission device to emit an x-raywhich projects a cone at an angle θ onto the sensor.

While the telescoping cone adjustment mechanism described with referenceto FIGS. 16-19 is preferred, those of skill in the art will appreciatethat a more conventional adjustable aperture (i.e., with translatablex-ray absorbing or blocking blades) may instead be used. The same mathused above is applicable to this embodiment; that is, if the distance isoutside an acceptable range of x-ray emission then no x-rays will beemitted. Conversely, if the distance between the x-ray origin and thesensor (d_(s)) are within the acceptable range, the aperture will beautomatically opened or closed to facilitate firing of the source.

Different markets have different safety requirements. Additionally,depending on the subject (elderly, pediatric, otherwise healthy) thelockout may be adjusted to ensure that there are no safety issuesassociated with the emission. The device also preferably includes thecapability to intelligently conserve power by utilizing the inertialmeasurement unit (IMU), distance sensor unit, as well as the operatorinitiated command inputs. The various durations for the power stages ofthe unit are user configurable so that the device can match the user'sspecific style and cadence.

The systems and methods described herein can also use multiple sensorsfor error correction and/or to improve positioning. For example, if anemitter and detector/sensor are in a given position and the system losestracking of one or more sensors on the platform ordinarily the loss intracking might cause a reduction in the frames per second (FPS) of theoutput image.

To address this situation, the emitter can include one or more inertialmeasurement units that can track movement of the emitter to adjust theintervening frame especially when needed. The IMU will then be used toadjust the intervening frames to increase the FPS of the output. In somevariations, with IMU's of sufficient accuracy, the IMU can be used inplace of or in addition to sensors on the platform.

A representative sequence for power management is shown in FIG. 5.

502. The user initiates the power sequence on the device by pushing aphysical button (i.e., 208 in FIG. 2) on the emitter. This engages thedevice's electronics and moves the device into ON mode.

504. Picking up the device is detected by the IMU in the emitter andimmediately raises the power level to STANDBY. This STANDBY stateinitializes all power systems and raises the charge of the power supplyto a medium level.

505. If the user sets the device down or is otherwise not interactedwith, either through movement of the emitter or through the initiationin the control panel or control computer, the device will automaticallypower down to the OFF stage after a duration of t0.

506. The user has picked up the unit and has engaged the unit, eitherthrough altering of settings on the control panel itself or by bringingthe device within range of a subject as detected by the onboard distancesensor. This further elevates the power level of the device by fullycharging the power system to a state where the device is ready to fire,bringing the device into READY mode.

507. If, after a duration of t1 without actively engaging the unit, theemitter will power itself down to the STANDBY level.

510. The user initiates an x-ray capture by depressing the trigger 202on the emitter. Assuming that all other safety checks are cleared, thisfurther engages the power supply and emits the stream of x-ray photonsat the subject until a state of 511, at which time the emission iscomplete. The user can continue to emit x-ray photons indefinitely at510′, 511′, however, as the device returns to READY mode.

511. After a duration of t2 during which time the emitter has not beenfired, the device will automatically power itself down to the STANDBYlevel at 520.

As shown with points 508, 522, 524, the device will follow the abovetimings to transition the device from the ON stages and finally to theOFF stage as the various durations elapse without positive engagement tomaintain or change the power state. By utilizing these steps, the devicecan conserve power while maintaining in a ready state without anyinteraction from the user.

FIG. 6 illustrates a process by which the device captures concurrentimages at the request of the user. Using the settings on the emitter'scontrol screen, or by specifying a concurrent capture in the controlunit, the emitter will initiate a process to capture any combination ofx-ray, traditional digital and/or thermal images. The process to capturethe images is as follows:

602. The user initiates the capture sequence on the device by pullingthe trigger of the emitter. This begins the capture process andconcurrent imaging process for whatever grouping of sensors is enabled.

604. The emitter immediately engages the X-Ray standby mode, preparingto fire the x-ray generator.

604′. Concurrently, if enabled, the traditional camera component focuseson the desired subject. This preferably occurs as soon as the trigger isdepressed.

604″. Concurrently, if enabled, the thermal camera is powered on andbegins its start sequence. This also preferably occurs as soon as thetrigger is depressed.

606. The x-ray system begins its safety checks, as illustrated in FIG.4.

608. The digital imaging camera captures a traditional image of thesubject. The image is preferably automatically transferred to thecontrol unit for display on an external monitor.

610. The thermal camera captures a thermal image of the subject. Theimage is preferably automatically transferred to the control unit fordisplay on an external monitor.

620. In the preferred embodiment, after both 608 and 610 have completed,and all safety checks from 606 have been verified, the x-ray unit willfire an emission, generating an x-ray image in the sensor. The image ispreferably automatically transferred to the control unit for display onan external monitor. Thus, the x-ray system will charge, verify safety,and discharge the x-ray only after all other systems have executed tominimize operational interference.

X-Ray Detector Implementations

The emitter described herein must be used in conjunction with an x-raydetector to gather radiographic imagery. The emitter is not limited interms of detector technology, and may be used with any availableflat-panel detector, even film. However, given fully portable nature ofthe emitter, steps should be taken to ensure that the emitter isproperly oriented with respect to the detector to gather clear imagerywhile avoiding spurious or unwanted x-ray emissions. One option is tomount the emitter in a fixture including a properly aligned detectorplate, much like a traditional c-arm though much smaller and morecapable. A preferred option, however, is to use the emitter with thex-ray capture stages described below, one of which includes an embeddedsensor that automatically pivots, orients and aligns itself with theemitter to maximize exposure quality and safety.

The preferred x-ray capture stage includes a statically fixed platform,positioned during the outset of surgery, with an interior cavitycontaining an x-ray sensor, an x-ray sensor positioning system, anemitter tracking system, a shielding system and a control unit. Thex-ray capture stage is adapted to receive an x-ray emission from aseparate emitter device, including the portable, hand-held unitdescribed herein. The x-ray capture stage preferably also incorporateswireless (or wired) communications capabilities enabling review of acaptured x-ray or fluoroscopic image to reviewed on an external displaymonitor or any other arrangement for the captured image includingexternal storage.

There are broadly two capture stage embodiments. In a clinicalembodiment, the stage tracks the emission and simply locks out the x-rayfiring if it is not in line. A tracking stage embodiment also permits orlocks out emission in accordance with alignment, but also preciselytracks the position and angle of the x-ray emission, positioning andtilting the embedded sensor to capture a precise, high quality x-rayimage. This arrangement uses less power, corrects for any skew orperspective in the emission and allows the subject to remain in place,thereby enabling the surgeon's workflow to continue uninterrupted andcapture x-rays without repositioning equipment, the subject or thesurgeon.

FIG. 7 is a simplified view of a preferred embodiment of the x-raycapture stage, which includes a platform 702 with a hollow cavityincluding the embedded sensor 706. In one configuration, the stage mighthave legs 703 and be used as a table. In another configuration, thestage might be wrapped in a bag and positioned underneath a patient.Thus, the platform 702 can be wrapped in a sterile drape and surgicalprocedures can be performed upon a platform such as table 105 in FIG. 1.

The capture stage cooperates with a separate x-ray emission device 710.There are a number of different configurations and implementations ofthe x-ray emission device besides the hand held unit described in detailabove, including wall-mounted, armature-mounted, and floor-mounted. Anyimplementation is compatible with the operative x-ray stage as long asthe electronic systems of the emitter can communicate with the interfaceof the operative x-ray stage central control unit to provide forpivoting, orientation or alignment.

The platform 702 is in electrical communication with a central controlunit 704. A display monitor 712, electronically connected to the controlunit 704, which may be used to both display images and provide overallsystem control. Generally, a user will interact with the emitter 710;however, in some cases, a user may interact with the central controlunit 704 directly to manipulate images, setup specific capturescenarios, control parameters or adjust other settings. The system mayalso use a tablet, mobile phone or any other display deviceelectronically connected to the central control unit for displaypurposes. The central control unit 704 and display may be combined in asingle device, such as a laptop computer or other mobile computingdevice. Optionally, the central control unit can be electronicallyconnected to multiple display units for educational or other purposes.

FIG. 8A is an oblique view of an x-ray capture stage according to theinvention. In one specific arrangement the stage comprises is a hollow,sealed, shell that is roughly 20″×30″, although the overall size of theinvention can be changed to conform to other surgical applications. Theshell creates a cavity 800 housing an x-ray detection sensor 706operative to capture an x-ray emission from an x-ray emitter. Suitablex-ray sensors are available from a variety of commercial manufacturers.The sensor 706 is attached to a motorized movement system used to panand tilt the sensor within the cavity. This motorized system ensuresthat the sensor is precisely positioned for maximum image quality andcapture view.

The x-ray sensor 706 is preferably mounted to a movable tray 802 thattravels under controlled movement within the cavity 800. The tray andsensor can move in the x-y direction and tilt along both axes asdescribed below. FIG. 9 is a diagram of a capture stage seen from above.The sensor 706 in tray 802 is mounted to translate on a series ofmotorized rails 720, 722, allowing the sensor to position itselfanywhere along the x and y axis within the shell. At least one of the xand y tracks may be a threaded rod, for example, each being driven by amotor for precise lateral movement of the tray 802 in the x and ydimensions. As a further alternative the x-y movement of the tray may becontrolled with bands 1002, 1004 in FIG. 10A. Such bands are preciselycontrolled by rods 1006, 1008, causing tray supports 1110, 1112 totranslate tray 808. Note that while four tray supports 902, 904 aredepicted in FIG. 9, single supports 1110, 1112 may alternatively be usedas shown in FIG. 10A.

FIG. 10B is a schematic diagram of a band-operated stage with anidentification of important components. The X-ray detector is shown at1030, and the detector carrier is depicted at 1032. This particularembodiment is driven by an H-shaped belt 1040. Items 1042 and 1044 aresmall and large offset bearings, respectively. The belt is driven bymotors 1050, 1052. The stage housing is shown at 1060, and power isbrought in via cable 1062. The detector tilt motors are indicated at1070, 1072. IR positioning tiles and IR emitters described withreference to FIG. 8B, are shown at 850 and 852, respectively. Thetypical IR emitters described herein are active beacons since theyactively emit a signal or energy that is received by the emitter to aidin determining a position of the emitter. Alternatively, or incombination, additional variations of the methods, systems and devicesdescribed herein can include passive markings or objects to aid indetermining orientation of the emitter. The systems, devices and methodcan include camera or emitter that simply record a specific pattern(e.g., a QR symbol or some unique object in the surgical area such as aclock, table, fixture, etc.). The system will then rely on a computer touse these patterns in place of, or in combination with, IR beacons todetermine a position of the emitter. In this latter case, the emitterposition is calculated by the computer or other processing unit.

In all stage embodiments, the upper cover of the platform or shell iscovered with a radiolucent material (i.e., 1018 in FIG. 10A). However,the lower base of the platform (i.e., 1020 in FIG. 10A) is preferablycoated with an x-ray absorbing material such as lead. This coatingprevents the excess x-rays from penetrating through the field and beingabsorbed by the operator of the emitter. This x-ray absorbingundercoating also prevents excess x-ray emission from bouncing off thefloor and scattering throughout the facility. The sides of the platformmay be constructed from a radio-opaque material as well.

FIGS. 11A, 11B are diagrams that show a pan and tilt mechanism. In FIG.11A, the sensor tray 802 is positioned within the cavity and the sensor706 is tilted around the y-axis. In FIG. 11B, the sensor tray 802 istilted along both the x-axis and the y-axes. This panning and tiltingallows the sensor to be precisely positioned to capture an x-ray imagewhile minimizing the distortion created by the offset angle of theemission device. That is, the capture stage and x-ray emitter arecoordinated to minimize skew and maximize capture of both x-ray andfluoroscopic images. By moving the sensor within the stage, the userdoes not need to reposition the subject to get a clear, usable x-ray orfluoroscopic image.

In the case of a handheld emitter, wherein the emission device isphysically decoupled from the stage, it is important to position thesensor relative to the emitter for quality and safety reasons. Differenttechniques may be used to accomplish this goal. As shown in FIGS. 8 and10, a plurality of position tracking implements 830 may be mounted tothe ends or corners of the tray. While these implements may be used inall four corners, only one is necessary for accurate triangulation.These implements may be based upon ultrasonic tone generation orinfrared emission. In these embodiments, acoustic or infrared signalsgenerated in the platform are detected by the emitter device, causingthe sensor to translate and tilt to maximize capture. A furtherembodiment may utilize magnetic position and orientation sensors anddetectors of the type used in surgical navigation to orient the tray andx-ray sensor.

The emitters 830 are used to measure the distance from a point 810 onthe hand-held unit 710 to three (or more) fixed points 830 attached thestage. These distances are depicted as D₁, D₂ and D₃ in FIG. 8A. Basedupon these distances, the system employs a tracking method to preciselylocate a center point 801 on the sensor 706 and angle (θ₅) of theemission from the source to the platform. An exemplary implementation ofthis tracking system would include a combination of infrared sensorswithin the platform and the hand-held unit, as well as a gyroscope inthe stage and hand-held unit to detect the angle θ₅.

The positioning of the detector uses a number of sensors in concert.When the user picks up the hand-held unit, the system enters a readystate. The infrared beacons on the corners of the table illuminate. Thepositioning tracking camera on the hand-held unit immediately startsanalyzing the infrared spectrum captured within a 140-degree field ofview. The camera is searching for patterns of infrared light. Eachcorner 830 has a specific pattern that determines which corner of thestage the infrared camera in the hand-held unit is looking at.

Making reference to FIG. 8B, an IR positioning emitter tile 850 sits ateach corner of the operative or clinical stage. The diagram is anexample of four unique tiles. When using the mounted positioningbeacons, the pattern will be different. These tiles contain a number ofinfrared emitters 852, usually five individual emitters, arranged in aspecific pattern. Each tile contains a different pattern of the five IRemitters. As the operator moves the x-ray emitter around the stage, theIR positioning camera captures and analyses the IR emissions from thetiles. Because each tile has a unique pattern, the camera is able todetermine its exact position in relation to the table. Additionally,because each tile has a unique pattern of multiple lights, the systemcan determine the exact position from the tile in XYZ space.

Optionally, or in addition to this unique IR layout, the IR emitters canflash in a syncopated manner. By modulating the frequency of theflashes, it is possible to add an additional uniqueness signature toeach tile, allowing patterns to repeat in a scenario with a large numberof tiles. Because of this unique arrangement, only a single corner ofthe unit, or single positioning beacon, needs to be visible to theemitter to allow the system to fully function. That is, due to thelayout of the pattern, the camera can triangulate its position in spacerelative to each corner. By using the triangulation data, as well as theorientation data from the IMU unit on the emitter, the system candetermine the center point of the emission. The stage will then move thecenter point to that area of the stage and tilt the detector to be asperpendicular to the emission as possible. While the sensor is movingitself into position, the collimator on the emitter adjust the output ofthe beam to ensure that it is illuminating the detector panel only.

The position information from the combination of the sensors 830 isrouted through the control unit (i.e., 704 in FIG. 7), whichinterpolates the raw sensor data into an aim point on the platform. Theplatform then moves the sensor tray 802 to the specified point. Theplatform then tilts the sensor into the correct orientation (θ₅) toremove as much skew as possible. Stated differently, assuming the x-raysource in emitter 710 emits radiation with respect to an axis 803, thegoal is to place the axis 803 as close as possible to the center point801 of the sensor, with the plane of the sensor being as perpendicularas possible to the axis 201 to minimize skew.

The x, y, pan and tilt positioning of the tray and sensor may beaccomplished without position emitters in the platform portion of thesystem. FIGS. 12A and 13 illustrate an alternative system and method ofposition calculation that removes the dependency of having positionemitters embedded in the table. Instead, the position of the x-rayemitter in relation to the capture stage and x-ray detection sensor canbe calculated based on external position emitters. As noted above, theemitter can be purely hand-held to allow a practitioner to move theemitter in free-space. Alternatively, the emitter can be moveable with(or coupleable to) a support structure that maintains the emitter inposition relative to the object without requiring the physician tocontinuously hold the emitter.

The process to determine the location of the x-ray emission device inaccordance with this embodiment is as follows:

The external positional emission device(s) are installed onto a fixedlocation and contain a series of infrared emitters. This emission devicereleases infrared patterns from 5 sides of a cubic object 1202 resultingin infrared energy being sent out from slightly different origins.

The stage detects the infrared pattern and calculates the relativeposition from the stage to the center of each infrared emitter in3-dimensional space. This position will be considered [xsi, ysi,zsi]=[−xei, −yei, −zei] with s representing the stage, e representingthe infrared emission device, and i representing the index of theinfrared emission device (if leveraging multiple infrared emitters).

The x-ray emission device continually detects the infrared signalpatterns and determines the relative location of the emission device tothe center of each infrared emitter in space. This relative position isrelayed to an emission position control unit for each emitter. Thisposition may be considered [xhi, yhi, zhi]=[−xei, −yei, −zei], with hrepresenting the x-ray emission device, e representing the infraredemission device, and i representing the index of the infrared emissiondevice.

The emission position control unit will receive the relative positionsof the x-ray emission device ([xhi, yhi, zhi]). Using these relativepositions, the emission position control unit calculates the position ofthe x-ray emission device relative to the stage (FIG. 13), resulting in[xhi-xsi, yhi-ysi, zhi-zsi]. This operation is performed for eachinfrared emission device (i), which can then be used to deduce themargin of error.

After the stage applies the position along with the other pieces of dataas mentioned in the original filing, the stage moves and rotates thex-ray sensor plate into the correct position to capture the x-ray image.

FIG. 12B illustrates a variation where an emitter 710 can apply energyto a sensor/detector 706 that is configured to move as discussed hereinbut can also move to enable a lateral image. In the illustratedvariation, the sensor/detector 706 moves outside of the center X axis ofthe table 105 to capture lateral views of the patient 104. However,variations of the sensor 706 can include configurations where the tableis non-planar and is configured to receive the sensor 706 above a planin which the patient is positioned. FIG. 12B also illustrates anadditional concept where multiple detectors 706 are used as describedherein. In such a variation, the sensors 706 would be moved as describedherein, but the sensor having the best operational alignment would beused to generate a signal.

Safety Lockout Procedures

Just as it is important to limit emissions from the emitter to specifictarget distances, for a variety of reasons, both practical andcertification, it is important to only fire the x-ray generator when theemitter is properly aimed at the capture stage. By preventing the x-raygenerator from emitting photons while not pointed at the stage, thesafety of the system is improved and the performance of an emitter isincreased. FIG. 14 illustrates the process by which the device managesthe safety lockout of the emitter and captures an x-ray image, with thenumbers corresponding to the numbers in FIG. 14:

1. User initiates the capture process by signaling through the emissiondevice 110, typically by depressing a trigger. The emitter sends a datapacket (D) to the controller containing the request for capture, thedistance measurements (d1, d2, . . . ) and the angle of the emitter.

2 a. The Controller validates that the emitter is in a safe orientation.

2 b. If the Controller discovers that the emitter is not in a safe,valid orientation, the controller sends an error message to the emitter.This prevents the emitter from firing and signals to the user that thereis a problem.

3. The stage positions the sensor in accordance with the position of theemitter. The stage will tilt the sensor so that it is in the correctorientation to capture a clear image. The orientation will be as closeto the complementary angle of the emission as possible.

4. The stage then sends a confirmation message to the controller afterthe position has been established.

5. The controller forwards the start message to the emitter. The emitterwill then execute any additional safety or preparation tasks. If theemitter believes the environment is safe to fire, the emitter will thenfire the x-ray.

6 a. The emitter fires a pulse of x-ray photons at the stage for therequested amount of time.

6 b. During the emission of the x-ray photon stream, the emitterconstantly streams any updates to the position and angle to the centralcontroller.

6 c. The controller records these positional updates and relays them tothe stage.

6 d. The stage will rapidly and constantly update the position and angleof the sensor to optically stabilize the x-ray image.

7. The sensor captures the emission of x-ray photons from the emitterand builds an image.

8. Upon completion of the x-ray emission, the sensor relays the data tothe control unit.

9. The control unit then cleans up the image from the sensor using avariety of know optical enhancement techniques. If applicable, thecontrol unit will leverage the stored movement data from the emitter tofurther enhance the output.

The above process allows the emitter to ensure that the emission will bedirected at the sensor and the stage as opposed to any other arbitrarytarget. By moving the sensor into place below the emission target, theuser can create a resolute, flexible image of the exact desired portionof the subject without having to reposition the subject.

FIG. 15 illustrates the process by which the device captures afluoroscopic image. The process for capturing a fluoroscopic image isvery similar to capturing a static x-ray image; however, thefluoroscopic process will repeat several emissions and image captures tocreate a moving image. The process to insure the safe emission as wellas capture the fluoroscopic image, with the numbers corresponding to thenumbers in FIG. 15:

1. User initiates the capture process by signaling through the emissionhandle, usually by depressing a trigger. The emitter sends a data packet(D) to the controller containing the request for capture, the distancemeasurements (d1, d2, . . . ) and the angle of the emitter.

2 a. The Controller validates that the emitter is in a safe orientation.

2 b. If the Controller discovers that the emitter is not in a safe,valid orientation, the controller sends an error message to the emitter.This prevents the emitter from firing and signals the user that there isa problem.

3. The stage positions the sensor in accordance with the position of theemitter. The stage will tilt the sensor so that it is in the correctorientation to capture a clear image. The orientation will be as closeto the complementary angle of the emission as possible.

4. The stage then sends a confirmation message to the controller afterthe positioning.

5. The controller forwards the start message to the emitter. The emitterwill then execute any additional safety or preparation tasks.

In the fluoroscopic mode, the emitter will repeat the following stepswhile the emitter device continues to request additional fluoroscopicframes, as follows:

6 a. The emitter fires a pulse of x-ray photons at the stage for therequested amount of time.

6 b. During the emission of the x-ray photon stream, the emitterconstantly streams any updates to the position and angle to the centralcontroller. If at any time during the fluoroscopic process, theoperative stage detects the emission is not aimed at the stage, thestage will send a termination signal to the emission device and skipdirectly to step 9.

6 c. The controller records these positional updates and relays them tothe stage.

6 d. The stage rapidly and continuously updates the position and angleof the sensor to optically stabilize the x-ray image.

7. The sensor captures the emission of x-ray photons from the emitterand builds an image.

8. The sensor immediately transfers the image to the control unit. Atthis time, a brief cleanup process is executed and the image isdisplayed on the external viewing device. This fluoroscopic frame issaved to memory.

The constant repetition of this process creates a moving image on theexternal display. The process will repeat until the user releases thetrigger of the emission device.

9. Once the user releases the trigger of the emission device, thecontrol unit “cleans up” the stored frames from the sensor using avariety of known enhancement techniques. If applicable, the control unitwill also apply any stored movement data from the emitter to furtherenhance the output. The control unit will then combine the fluoroscopicframes into a single video for repeated playback.

The above process allows the user to see a live fluoroscopic view of thesubject in real time. By storing the images and reprocessing after thecapture is complete, the device can create a high quality, singlefluoroscopic video for display and review at a later time.

Self-Adjusting Collimator

As noted above, the systems of the present disclosure allow for movingan emitting apparatus to a location relative to the object and determinea position of the emitting apparatus relative to at least one positiontracking element where the at least one position tracking element,measures a distance between the emitting apparatus and the object andpreventing emitting energy until the distance is less than apre-determined distance. Variations of the systems described herein canuse a self-adjusting collimator that optimizes a profile or boundary ofthe emission onto the working surface of a sensor. As with othervariations described herein, these systems can relay the position of theemitting apparatus to a motor system that adjusts an imaging sensor intoan operative alignment with the emitting apparatus where relaying theposition of the emitting apparatus includes using the emitting apparatusto both provide an orientation data of the emitting apparatus anddetermine a distance from each of the plurality of tracking elements.However, the use of a self-adjusting collimator allows for automaticmaximization of an emission profile on the imaging sensor.

To illustrate the benefit of an adjustable collimator, FIG. 20illustrates a representation of an x-ray emitter 110 directed towards atable 114 having an imaging sensor (not shown) located therein. Theperimeter of the working area 116 of the imaging sensor is shown toillustrate the area that will produce an image upon exposure to an x-rayemission. As shown, a profile of an x-ray emission 120 from x-rayemitter 110 extends beyond the perimeter of the working area 116 of theimaging sensor causing the x-ray emitter to be out of operativealignment with the sensor. In such a case, the system as describedherein will not permit firing or initializing of the x-ray emitter 110.The illustration of FIG. 20 is intended to illustrate a concept of thesystem being out of operative alignment. As noted herein, the imagingsensor can be coupled to a motor system to permit movement of the sensorinto alignment with the emission profile 120. Alternatively, the table(or operating surface) 114 can include a plurality of position trackingelements (not illustrated in FIG. 20) that allows determination of theposition and distance of the emitter 110 relative to a non-moving sensoror the sensor's working area 116.

FIG. 21A represents a situation in which an emission profile 120 extendsbeyond the sensor 116 such that the emitter is not in operativealignment with the sensor 116. For purposes of illustration, the sensor116 shown in FIGS. 21A and 21B is stationary and tracking elements 118permit the system to determine the relative location, orientation, anddistance of the emitter (not shown) relative to the sensor 116. Also,the emission profile 120 is illustrated as a representation of aboundary of the emission provided by the emitter. For purposes ofillustration, the profile 120 illustrated is a profile that would occurif an axis of the emitter is perpendicular to the sensor 116.

As noted herein, if the system cannot establish operative alignmentgiven the condition shown by FIG. 21A, the operator will be prompted toadjust a position of the emitter. In some variations, the system canprovide feedback such as an audible or visual indicator ofnon-alignment. FIG. 21B shows a situation after repositioning of theemitter such that the emission profile 120 falls within the boundary ofthe sensor 116. However, as shown, this emission profile 120 is notmaximized to the dimensions of the sensor 116. Failure to maximize theemission profile 120 relative to the sensor can require the operator totake additional radiological images of the subject to adjust for asmaller profile.

FIG. 22A illustrates the effect of an adjustable collimator. Again, forpurposes of illustration, the emission profiles shown representillumination by an emitter that is perpendicular to a sensor. FIG. 22Ashows an unadjusted emission profile 120 that would ordinarily beconsidered out of operative alignment with the imaging sensor 116 giventhat a portion of the emission area bound by the profile 120 fallsoutside of the sensor 116. However, a variation of the system describedherein will rely on the position tracking elements 118 as well ascomponents affixed to the emitter (as described above) to determinepositional information such as an orientation of the emitter as well asa distance between the emitter and the sensor 116. The system will usethe positional information to adjust a collimator on the emitter torotate and/or scale emission by the emitter to produce an adjustedemission profile 122. As shown, in this variation, the adjusted emissionprofile 122 is reduced in size (denoted by arrows 126) and also rotated(denoted by arrows 124) to scale the emission profile 120 into anadjusted emission profile 122 that maximizes an exposure onto theimaging sensor. It is noted that the adjusted emission profile can bescaled or rotated as needed. Moreover, variations of the system willproduce an adjusted profile during real-time movement of the emitterrelative to the sensors 118.

FIG. 22B illustrates an unadjusted emission profile 120 along with theadjusted emission profile 122, where in both cases, the profileresembles an isosceles trapezoidal shape due to an axis of the emissionpath not being perpendicular or normal to the sensor 116. However, inthis variation, the system uses the positional information to produce anadjusted profile 122 that maximizes an exposure area on the image sensor116.

While the variations disclosed herein rely on tracking elements 118 aswell as sensors within the emitting unit (as described herein).Variations of the system that produce an adjusted emission profile canalso be used with positional data that is derived from external cameras,sensors, or mechanical supports to determine relative movement betweenan emitting apparatus and an imaging sensor.

FIG. 23 shows a variation of an adjustable collimator 130 that can beused in or with an emitting apparatus (not shown in FIG. 23). Asillustrated, the adjustable collimator 130 can rotate and/or scale anaperture or emission window 132 to produce an adjusted emission profileupon an imaging sensor (as discussed in FIGS. 20 to 22B). This variationof the adjustable collimator 130 uses a number of blades or leaves 134that can move and rotate to adjust an orientation of the aperture 132.The blades 134 prevent passage of the emitted energy such that energy islimited to pass through the aperture or emission window 132.

The movement and rotation of the blades can be driven by any number ofmotors or drives. In the variation shown, the adjustable collimator 130includes a motor assembly having a first drive 138 coupled to a proximalslewing bearing 152 and a second drive 136 coupled to a distal slewingbearing. The drives 136 and 138 adjust the rotation of the blade 134 sas well as a sizing of the aperture 132. For example, rotation of themotors 136 and 138 in opposite directions causes rotation of the slewingbearings in the opposite direction and produces movement of the blades134 to cause opening/closing of the aperture 132. In the example shown,if the first drive 138 moves in a clockwise direction and the seconddrive 136 moves in a counter-clockwise direction, then the blades 134will move towards each other causing a size of the aperture 132 todecrease. Likewise, if the first drive 138 moves in a counter-clockwisedirection and the second drive 136 moves in a clockwise direction, thenthe blades 134 will move away each other causing a size of the aperture132 to increase. If the drives 138 and 136 move in the same direction,this will cause rotation of the proximal and distal slewing bearings 150and 152 in the same direction, which will cause rotation of the blades,which causes rotation of the aperture 134.

The adjustable collimator 130 maintains an aperture 132 having anear-square shape since all of the blades 134 move to adjust the size ofthe aperture. Additional variations of the device can include any numberof additional motors or actuators to also control an angular orientationof the blades. In such a case, the aperture 134 is not limited to asquare profile and can assume an isosceles trapezoidal shape. Such afeature can assist in maintaining a square emission profile (such asthat shown in FIG. 22A) regardless of the orientation of an axis of theemission energy to the imaging sensor.

The variation of an adjustable collimator 230 shown in FIG. 23 alsoincludes a chassis or housing 140 that houses the drive mechanism (e.g.,bearings, pulley 144, belts 146, etc.) that translates the movement ofthe gears 144 driven by motors 136, 138 into rotation and movement ofthe blades. Furthermore, the adjustable collimator 230 will include anynumber of positioning tracking systems that enables the system tomaintain information regarding a size and rotational orientation of theaperture. For example, a first moveable disk (or encoder wheel) 142 isshown as part of an optical encoder system that can use any conventionallight source, sensor, mask, and photosensor (e.g., a photodiode).

FIG. 24A shows an exploded view of an example of an adjustablecollimator 130 to illustrate a variation of the mechanism used to rotateand scale the aperture 132 formed by the blades 134. As illustratedpulleys 144 coupled to the motors 136 and 138 rotate belts 146 that arecoupled to a cam/pin assembly 148. The blades 134 are housed in thecam/pin assembly 148 but for purposes of illustration, the cam/pinassembly 148 is shown without the blades. The assembly 148 comprises acam wheel 150 and a proximal slewing bearing 152 that are each coupledto a respective motor 136 and 138 via the belt system 146. The blades134 coupled to one or more pins 154 within the assembly 148 of slewingbearings 150 and 152 such that rotation of the slewing bearings 150 and152 causes a scaling of the aperture 132 as discussed above. Thisscaling is caused through movement of the blades 142 closer or fartherapart. The rotation of the aperture 132 is caused by rotation of theslewing bearings 150 and 152 in the same direction

FIG. 24B illustrates a front view of some of the components of theadjustable collimator 130 (a number of components are removed for thesake of illustration). As shown, the aperture 134 is defined by areasurrounded by the blades 134. Each blade is coupled to a pin 154 at oneend. The opposite end of the blade 134 includes a bearing 158 within aslot 156. Actuation of the motor 138 causes movement of the bearing 158within the slot 156 while the blade 134 pivots about the pin 154, whichcauses the blades to move closer together or farther apart (dependingupon the direction of rotation) at the aperture 132 to produce a scalingof the aperture 132. Rotation of the aperture 132 occurs when motor 136causes rotation of the cam wheel 150 (shown in FIG. 24A). As notedabove, rotation of the aperture 132 requires rotation of the slewingbearings 150 and 152 in the same direction.

FIG. 24C illustrates a rear view of some of the components of theadjustable collimator 130 (a number of components are removed for thesake of illustration). As shown, the collimator 130 includes a secondmoveable disk (or encoder wheel) 160 that is shown as part of an opticalencoder system that can use any conventional light source, sensor, mask,and photosensor (e.g., a photodiode) to track movement of the blades134.

FIGS. 25A and 25B illustrate an example of an emitter 164 having anadjustable collimator 130 as discussed above. As shown, the adjustablecollimator can rotate and scale the aperture 132 based on informationregarding the distance and orientation of the emitter from the system'sposition tracking elements. The scaling and rotation of the aperture 132can be automatic or can occur on demand. FIGS. 25A and 25B show avariation of the emitter having cabling 166. In other variations, theemitter and adjustable collimator can be used on a fully portableemitter as described herein.

The optical encoders 160 in FIG. 24C ensures leaf or blade positioningto ensure patient safety. The encoder 160 can also assist in determiningany number of conditions that could create a failure state: For example,the encoders can detect conditions, including but not limited to: drivebelts skipping a tooth on the gear, drive belts breaking or losingtension, motor malfunctions, broken ring gear, broken leaf pin, etc.Detection of such failure state can prevent the emission source fromtriggering to avoid exposing the patient or operator to excessradiation.

FIGS. 26A to 26J illustrates an example of a validation method for thecollimator discussed herein. The rolling collimator has two processesthat are executed to validate the mechanical operation and alignment ofthe device. Due to the emission of ionizing radiation from the x-raytube, it is imperative that the mechanical function the device bevalidated before use, discovering any physical damage before exposingthe operator to additional radiation. The freely mobile, untethereddesign of the device creates an additional challenge for the collimator:indexing the position of the wheels to an arbitrary alignment of thex-ray detector. The collimator executes a homing process to determinethe min/max aperture positions and the 0° position of the device. Thehoming process establishes the zero-orientation reference required forcollimator aperture control. The leaf detection process validates thephysical operation of the device by verifying the full range of aperturesizing.

FIG. 26A shows a random position of the leafs of the collimator device.This position could be the orientation of the device after a previousoperation, from a previous procedure or any other scenario. The devicehas no knowledge of the aperture or orientation until after the homingprocess. The device consists of (1) (2) (3) optical sensors to monitorthe position of leaves, (4) (5) motors to drive a distal slew ring (12)and a proximal slew ring (13) connected by a pair of belts (10) (11).The four collimation leaves (6) (7) (8) (9) are connected to the slewrings in pairs.

The optical sensors (1) (2) (3) operate by detecting the presence orabsence of leaf material directly in front of the sensor. The sensor isconsidered open if there is no material in front of the sensor. It isconsidered closed if the presence of the material is detected.

Homing Procedure

Step 1: Open Position—The homing procedure is executed any time thedevice is powered on, any time the device has been in an idle state orany time the device has detected drift. The device begins by rotatingthe proximal ring until the device detects movement in the distal ringby linkage. FIG. 26B shows the non-determinate position of thisscenario, illustrated by the visibility of the home keyway (14). Thisalignment allows the optical sensor 1 to detect an open state when thekeyway is directly in front of the sensor. This is the fully openposition of the collimator.

Step 2: 0 Degree Position, Maximum Aperture—FIG. 26C shows the 0 degree,maximum aperture position. Once the fully open position has beendetermined, the device will rotate the proximal and distal ringsconcurrently, rotating the leaf assembly. The system will monitor thestatus of optical sensor 1 until such a time as the sensor registersopen (15). This open signal indicates that the keyway has rotated intothe position of the sensor at the fully open position. The system thenregistered this as the fully open, 0 degree position.

Step 3: 0 Degree Position, Minimum Aperture—The device will then turnthe distal slew ring until such a time as it detects movement in theproximal slew ring. When this movement is detected, the system will thenregister the 0 degree, minimum aperture position as shown in FIG. 26D.

These positions are then registered for the current operational session.With the motor position recorded, the device can calculate the relativemovement of the motors and slew rings to any other necessary position.

Damage Detection Procedure

As described above, a fully operational, undamaged collimator isessential to the safety and performance of the collimation system.Furthermore, detecting and damage or drift is critical before anyemission is released through the device. In order to guaranteeperformance, the device will consecutively check the positioning statusof each leaf

At minimum a single check of each leaf is necessary; however, due to thesafety nature of this process the exemplary device uses a three positioncheck. The optical sensor array (1) (2) (3) is used to validateindividual leaf performance but any number of sensors could be used toexecute the process. The order of the checks is can vary. Once the threestep process has been completed for the first leaf (16), the processwill the move on to validate leaf two (17), leaf three (18) and leaffour (19). The process is applicable to any number of leaves.

Step 1: Maximum Aperture Validation—Sometime after the homing processhas been completed, the device will roll the leaf assembly into OpticalSensor 1 closed position (20) FIG. 26E by moving both proximal anddistal rings as necessary to create the fully opened aperture. Thedevice will then immediately move into Optical Sensor 1 open position bymoving the rings to reduce the aperture FIG. 26F. If the calculatedmovements of the device match the physical feedback of Optical Sensor 1(21) the device has validated the maximum aperture position for leaf 1(16).

Step 2: Median Aperture Validation—Sometime after the homing process hasbeen completed, the device will roll the leaf assembly into OpticalSensor 2 closed position (22) FIG. 26G by moving both proximal anddistal rings as necessary to create the median aperture. The device willthen immediately move into Optical Sensor 2 open position by moving therings to reduce the aperture FIG. 26H. If the calculated movements ofthe device match the physical feedback of Optical Sensor 2 (23) thedevice has validated the maximum aperture position for leaf 1 (16).

Step 3: Minimum Aperture Validation—Sometime after the homing processhas been completed, the device will roll the leaf assembly into OpticalSensor 3 closed position (24) FIG. 26I by moving both proximal anddistal rings as necessary to create the minimum aperture. The devicewill then immediately move into Optical Sensor 3 open position by movingthe rings to reduce the aperture FIG. 26J. If the calculated movementsof the device match the physical feedback of Optical Sensor 3 (25) thedevice has validated the maximum aperture position for leaf 1 (16).

Once Step 3 has completed for Leaf 1, the device will then repeat theprocedure for each leaf, guaranteeing that each leaf is in the expectedposition.

FIGS. 27 and 28A-28B illustrate another aspect in which a radiologicalsystem having a sensor configuration as described herein can improve thequality of an x-ray or fluoroscopic capture.

The quality of an x-ray or fluoroscopic capture is related to a numberof physical attributes of the subject. These elements dictate a set oftechnique factors (eg: power, current, time, etc.) that control theemission characteristics of the radiation source/emitter. It is theresponsibility of the device operator to set these factors in such acombination that the individual viewing the radiological image canidentify the necessary visual elements without exposing the subject toexcess radiation.

Setting these technique factors can be complex. In order to relieve theoperator of the burden of setting these techniques manually, existingfluoroscopic devices have implemented an automatic process. The typicalapproach uses a software or a hardware dose detector on the plate thatgradually fills as radiation is added to the exposure. This conventionalapproach has a number of problems.

One major issue with the conventional approach is movement. Because theradiation is exposing the subject for an extended time period, anymovement whatsoever, either in the subject, the operator, the machine,vascularity inside the subject, etc., creates motion artifacts thatseverely degrade the image.

Another issue is that penetration requirements are not known before theexposure; therefore, as the source emits radiation at a given powerlevel (kV), frequently there is not be enough penetration to render animage. This failure to render an image exposes the patient, operator andstaff to radiation without producing any useful radiological image. Insuch a case, these individuals are exposed to excess radiation that doesnot serve any clinical purpose.

Innovation in the fluoroscopic device space, including but not limitedto the systems described herein, creates a new generation of machineswith complex sensor arrays, capable of directly measuring a number ofthe physical elements required for exposure calculation.

By utilizing these sensors across the full spectrum of devices andsubjects, as well as robust machine learning techniques, it is possibleto compute the necessary techniques before exposure, eliminating motionartifacts and creating an outstanding capture, all while reducing dose.

The following descriptions provide exemplary details of the invention inorder to provide an understanding of the invention. Small engineeringadjustments could be employed to practice the invention withoutemploying these specifics. While the invention is described for use inx-ray imaging for surgical purposes, it could be used in other medicalapplications including but not limited to general medical imaging,veterinary, and bone densitometry. It could be used for non-medicalapplications such as industrial imaging, metal fatigue inspections,weld-inspection, for security inspections, and the like.

FIG. 27 shows a diagram of an example of a conventional methodology forautomatic x-ray exposure process. The doctor or operator begins theexposure (step 1) by requesting the x-ray be taken. The x-ray devicewill then evaluate the detector (step 2), tracking the amount ofradiation received on the imaging sensor plate. An internal measurementof x-ray machine will determine if this energy is a sufficient amount ofexposure to generate an image (step 3). If the device determines that anadequate amount of radiation is collected (step 4 a), it will deem theexposure complete and display the x-ray. If the user cancels the x-rayor the dose has been accumulating for too much time, the machine willcancel the exposure (step 4 b.) Otherwise, (step 4 c) the device willcontinue to emit radiation, returning back to the evaluation step untilthe image is created, time runs out or the user cancels the exposure.

The traditional process has a number of drawbacks, the two largest arethat: exposure begins without a guarantee that an image will appear andthat the time taken to evaluate the exposure introduces movementartifacts in the final image, creating an unusable x-ray. In eithercase, the patient, operator and staff are exposed to unnecessaryradiation, which is a major safety hazard.

FIGS. 28A and 27B illustrates an improved approach over the conventionalmethodology described in FIG. 27. The improved approach can determinethe optimal technique factors to create a resolute and effectiveradiological image without exposing the operator, staff and patient tounnecessary or excessive radiation. By utilizing a radiological imagingdevice with a comprehensive sensor array and an enterprise wideapplication of machine learning techniques, the system 20 can calculateand refine the techniques before any radiation is emitted. This allowsan operator to precisely align the device and understand if the machineis capable of imaging the anatomy.

FIG. 28B illustrates an example of how statistical data can be compiledfor use in the imaging process of FIG. 28A. In practice, a number ofstatistical models are transmitted to the system 20 from a centralserver (shown in FIG. 28B). These models, referred to as the ComputerVision Classifier (1 a) and the Estimator Update (1 b) are storedlocally on the machine and ready for use prior to the operatorrequesting the exposure.

Turning to FIG. 28A, the process can begin with the operator initiatingthe capture (2). The operator then uses the positioning system of thedevice to align the emitter and anatomy (3), completing the safetychecks, then executing the automatic technique detection (as describedabove). Depending on the exact topography of the x-ray system, CPT Codeinformation (4 a) and or Biometric Information (4 b) may be entered byan operator or extracted from another system by automatic means.

As the system prepares to emit the energy for either x-ray orfluoroscopic capture, two concurrent measurement collections arehappening: on-device sensor collection (5 a) and computer visionclassification (5 b).

The sensor collection uses the array on the device to collect amultitude of input parameters, including, but not limited to,source-to-skin distance (SSD), source to detector distance (SDD), angleof incidence, ambient, x-ray tube and device temperature, etc. Theseparameters are all fed into the inference execution function (6).

The computer vision classifier utilizes the imaging camera on the deviceto capture pictures of the subject anatomy. These images are passed intothe CV analysis function, using the captured images as well as the CVClassifier data that is stored locally on the device, provided by thecentral server. These processes make a determination about that subjectof the capture and passes that recommendation to the Inference ExecutionEngine.

Once the inputs are collected from the device's various subsystems,those values, along with the Estimator Update provided by the centralserver, are run against the device's inference execution engine (6 a).The output of that function family is the determined x-ray technique:time, kV and beam current (7).

The device output is set to the computed values, radiation is emittedfor the given settings (8), the image is captured and processed (9) andthe image is displayed to the user. (10)

As soon as the x-ray is displayed to the operator, the systemimmediately begins monitoring the operator interaction in theInteraction Monitoring system (11). This system records everyinteraction the operator has with the image, that includes changes inbrightness, sharpness, contract, position, zoom, rotation, etc. Theamount of time the operator spends examining the x-ray or fluoroscopiccapture is also recorded.

In steps 12 a-12 d, the system will submit capture data to the centralprocessing system. The submitted data includes the four major componentsof the capture: (12 a) Direct Measurement Information, such a SSD,temperature, etc. (12 b) interaction heuristics, such as the changes inbrightness or the amount of time spent examining a capture. (12 c)includes the surgical detail, such as the biometric information, anyassociated CPT code as well as the computer vision captures andresulting classification output. (12 d) includes the raw capture datafrom the detector itself as well as capture associated information, suchas machine details, software versions, etc.

This capture information is stored on the central processing system inrespective databases 13 a and 13 b for future processing.

At a scheduled time, the central processing system will train theestimator labels (14) using a sophisticated regression analysis. Byexamining the statistical relationship between the sensor data, capturedata and surgical data across a large section of universally capturedx-rays, as well as the results of the previous estimator generation (14a), the system can fit data to more accurate labels. The output of thetraining step is a new estimator (17).

Like the label training step (14), the x-ray and fluoroscopic capturedata, surgical detail data and classifier data will be trained using aclassifier refinement process (15). This process uses the large capturecross section from the huge number of input x-rays to create a moreaccurate classifier (16).

Depending on the topography of the x-ray machines in the field, thecentral processing system will transmit the new estimator (18) andclassifier (19) to the devices as soon as possible. They will then loadthese updates into the device local storage (1 a) and (1 b) and applythe new algorithms to further enhance the accuracy and reduce the doseof the automatic exposure.

While the above descriptions provide exemplary details of the inventionin order to provide an understanding of the invention, routineengineering adjustments may be employed to practice the inventionwithout departing from the spirit or scope of the invention. Further,while the invention is described for use in x-ray imaging for surgicalpurposes, it could be used in other medical applications such as generalmedical imaging, veterinary and bone densitometry. The system and methodmay also be used for non-medical applications such as industrialimaging, metal fatigue inspections, weld-inspection, for securityinspections, and the like.

1. An emitting apparatus for use with a non-invasive imaging systemhaving an imaging sensor configured to generate an imaging signal uponan exposure of an energy, the emitting apparatus comprising: an energysource configured to generate the energy; an emission passage within theemitting apparatus and configured to direct the energy sourcetherethrough; a plurality of blades positioned within the emittingapparatus in a surrounding arrangement to form an emission window in theemission passage, where the emission window filters the energy passingthrough the emission passage, the plurality of blades housed in a bladehousing having a proximal bearing on a proximal side of the plurality ofblades and a distal bearing on a distal side of the plurality of blades;a motor assembly comprising a first motor coupled to the proximalbearing and a second motor coupled to the distal bearing; where rotationof the first motor and second motor in an opposite direction causesopposite movement of the proximal bearing and the distal bearing whichincreases or decreases a size of the emission window; and where rotationof the first motor and second motor in a similar direction rotates theproximal bearing and the distal bearing in the similar direction causinga rotation of the emission window.